Authorities in the fields of physiology and clinical medicine are in agreement that there is a need for an acceptable substitute for whole blood. Similar opinion exists regarding hematocrit.
In the prior art, a number of compositions, i.e.: Lactated Ringer's Solution, Dextran, Modified Gelatin, Hydroethyl Starch, Fluorocarbons and Perfluorocarbons are referred to as "blood substitutes". (Ref. Chemical Abstracts, 8th Collective Index, 1967-1971; 1972.) The scientific literature however, records no evidence that any of these compositions can function as a whole blood substitute or that they are conventionally used as such. These substances as well as albumin are employed principally to expand plasma volume, carry oxygen, or enhance oxygen transport. Whole human blood is known to possess other important capabilities and functions. Aside from intrinsic physiological limitations, the available "blood substitutes" have restricted utility by reason of known adverse reactions and incompatibilities.
With the exception of Applicants' U.S. Pat. No. 4,343,797, the prior art contains no reference to a blood substitute that has both the physico-chemical characteristics and the physiological range of whole blood. (Ref. Chemical Abstracts, 8th Collective Index, 1967-1971; 1972; Chemical Abstracts, 9th Collective Index, 1977; Chemical Abstracts, volumes, 88, 89, 90, 91, 92, 93 and 94.). Moreover, the cited prior art does not refer to a method of manufacture of such a composition. Finally, the scientific literature contains no reference to a blood substitute which like whole human blood and the claimed composition of matter possess both polar and non polar properties. Presently known blood substitutes are primarily either polar or non polar.
From Applicants' U.S. Pat. No. 4,343,797, it is now recognized that the physical-chemical structure of whole human blood has been successfully substantially replicated in a composition of matter known as Synthetic Whole Blood. It is now also recognized the Synthetic Whole Blood is a distinct entity fundamentally different from compositions known in the scientific literature as "blood substitutes".
Table I which follows details other fundamental differences between the claimed composition of matter and the available blood substitutes described in the prior art.